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초록

Objectives: This exploratory analysis investigated whether the disease-free survival (DFS) benefit seen with adjuvant alectinib versus chemotherapy in patients with resected, ALK-positive non-small cell lung cancer (NSCLC) from the phase III ALINA study (NCT03456076) was maintained across surgical characteristic subgroups and when re-classifying patients according to the 8th edition of the Cancer Staging Manual of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC). Methods: ALINA is a global, open-label, randomized trial. Eligible patients ≥ 18 years old with resected, ALK-positive NSCLC of stage IB (≥4 cm), II, or IIIA (per AJCC/UICC 7th edition) were randomized 1:1 to receive alectinib 600 mg twice daily for 24 months or four 21-day cycles of platinum-based chemotherapy. Primary endpoint: investigator-assessed DFS. Endpoints of this exploratory analysis included DFS by stage (8th edition AJCC/UICC), nodal status, tumor size, and other surgical characteristics, in the primary analysis population. Results: Patient characteristics were generally well balanced across both treatment arms; most patients had a tumor measuring ≤ 3 cm (n = 147 [57.4%]), stage IIIA disease (n = 134 [52.1%]), and regional lymph node stage N2 (n = 130 [50.6%]). Consistent with the primary results, patients receiving alectinib had longer DFS versus those who received chemotherapy, irrespective of disease stage (AJCC/UICC 8th edition), nodal status, tumor size, or other surgical characteristics. Conclusions: Alectinib is the first ALK inhibitor to show a consistent DFS benefit over chemotherapy in patients with resected early-stage ALK-positive NSCLC, regardless of disease stage per AJCC/UICC 7th or 8th edition, nodal status, or tumor size. Clinical trial registry number: NCT03456076.

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